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The Lancet. Global Health Apr 2024Although mpox has been detected in paediatric populations in central and west Africa for decades, evidence synthesis on paediatric, maternal, and congenital mpox, and... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Although mpox has been detected in paediatric populations in central and west Africa for decades, evidence synthesis on paediatric, maternal, and congenital mpox, and the use of vaccines and therapeutics in these groups, is lacking. A systematic review is therefore indicated to set the research agenda.
METHODS
We conducted a systematic review and meta-analysis, searching articles in Embase, Global Health, MEDLINE, CINAHL, Web of Science, Scopus, SciELO, and WHO databases from inception to April 17, 2023. We included studies reporting primary data on at least one case of confirmed, suspected, or probable paediatric, maternal, or congenital mpox in humans or the use of third-generation smallpox or mpox vaccines, targeted antivirals, or immune therapies in at least one case in our population of interest. We included clinical trials and observational studies in humans and excluded reviews, commentaries, and grey literature. A pooled estimate of the paediatric case fatality ratio was obtained using random-effects meta-analysis. This study is registered with PROSPERO (CRD420223336648).
FINDINGS
Of the 61 studies, 53 reported paediatric outcomes (n=2123 cases), seven reported maternal or congenital outcomes (n=32 cases), two reported vaccine safety (n=28 recipients), and three reported transmission during breastfeeding (n=4 cases). While a subset of seven observational studies (21 children and 12 pregnant individuals) reported uneventful treatment with tecovirimat, there were no randomised trials reporting safety or efficacy for any therapeutic agent. Among children, the commonest clinical features included rash (86 [100%] of 86), fever (63 [73%] of 86), and lymphadenopathy (40 [47%] of 86). Among pregnant individuals, rash was reported in 23 (100%) of 23; fever and lymphadenopathy were less common (six [26%] and three [13%] of 23, respectively). Most paediatric complications (12 [60%] of 20) arose from secondary bacterial infections. The pooled paediatric case fatality ratio was 11% (95% CI 4-20), I=75%. Data from 12 pregnancies showed half resulted in fetal death. Research on vaccine and immune globulin safety remains scarce for children and absent for pregnant individuals.
INTERPRETATION
Our review highlights critical knowledge gaps in the epidemiology, prevention, and treatment of mpox in children and pregnant individuals, especially those residing in endemic countries. Increased funding, international collaboration, and equitable research is needed to inform mpox control strategies tailored for at-risk communities in endemic countries.
FUNDING
None.
TRANSLATIONS
For the French, Spanish and Portuguese translations of the abstract see Supplementary Materials section.
Topics: Female; Pregnancy; Child; Humans; Mpox (monkeypox); Family; Exanthema; Lymphadenopathy; Vaccines
PubMed: 38401556
DOI: 10.1016/S2214-109X(23)00607-1 -
Journal of Clinical Medicine Nov 2023Antiviral treatment reduces the severity and mortality of SARS-CoV-2 infection; however, its effectiveness against long COVID-19 is unclear. This study aimed to evaluate... (Review)
Review
Antiviral treatment reduces the severity and mortality of SARS-CoV-2 infection; however, its effectiveness against long COVID-19 is unclear. This study aimed to evaluate the effectiveness of antiviral drugs in preventing long COVID and related hospitalizations/deaths. Scientific and medical databases were searched from 1 January 2020 to 30 June 2023. We included observational cohort studies comparing individuals receiving early antiviral therapy for COVID-19 and those receiving supportive treatment. A fixed-effects model was used to merge the effects reported in two or more studies. The risk of post-acute sequelae of COVID-19 (PASC) was combined as an odds ratio (OR). Six studies were selected, including a total of 3,352,235 participants. The occurrence of PASC was 27.5% lower in patients who received antiviral drugs during the early stages of SARS-CoV-2 infection (OR = 0.725; 95% confidence interval [CI] = 0.409-0.747) than in the supportive treatment group. Moreover, the risk of PASC-associated hospitalization and mortality was 29.7% lower in patients receiving early antiviral therapy than in the supportive treatment group (OR = 0.721; 95% CI = 0.697-0.794). Early antiviral therapy was associated with a reduced risk of PASC and related hospitalization or death. Thus, early antiviral therapy is recommended for at-risk individuals.
PubMed: 38068427
DOI: 10.3390/jcm12237375 -
Frontiers in Public Health 2023The purpose of this systematic review was to report on the vaccine efficacy (VE) of three SARS-CoV-2 vaccines approved by Health Canada: Pfizer BioNTech, Moderna, and...
The purpose of this systematic review was to report on the vaccine efficacy (VE) of three SARS-CoV-2 vaccines approved by Health Canada: Pfizer BioNTech, Moderna, and AstraZeneca. Four databases were searched for primary publications on population-level VE. Ninety-two publications matched the inclusion criteria, and the extracted data were separated by vaccine type: mRNA vaccines (Pfizer and Moderna) and the AstraZeneca vaccine. The median VE for PCR-positive patients and various levels of clinical disease was determined for the first and second doses of both vaccine types against multiple SARS-CoV-2 variants. The median VE for PCR-positive infections against unidentified variants from an mRNA vaccine was 64.5 and 89%, respectively, after one or two doses. The median VE for PCR-positive infections against unidentified variants from the AstraZeneca vaccine was 53.4 and 69.6%, respectively, after one or two doses. The median VE for two doses of mRNA for asymptomatic, symptomatic, and severe infection against unidentified variants was 85.5, 93.2, and 92.2%, respectively. The median VE for two doses of AstraZeneca for asymptomatic, symptomatic, and severe infection against unidentified variants was 69.7, 71, and 90.2%, respectively. Vaccine efficacy numerically increased from the first to the second dose, increased from the first 2 weeks to the second 2 weeks post-vaccination for both doses, but decreased after 4 months from the second dose. Vaccine efficacy did not differ by person's age.
Topics: Humans; COVID-19 Vaccines; SARS-CoV-2; Vaccine Efficacy; COVID-19; Vaccines
PubMed: 37942238
DOI: 10.3389/fpubh.2023.1229716 -
Clinical Microbiology and Infection :... Apr 2021While the landscape of vaccine and treatment candidates against the novel coronavirus disease 2019 (COVID-19) has been reviewed systematically, prophylactic candidates...
BACKGROUND
While the landscape of vaccine and treatment candidates against the novel coronavirus disease 2019 (COVID-19) has been reviewed systematically, prophylactic candidates remain unexplored.
OBJECTIVES
To map pre- and postexposure prophylactic (PrEP and PEP) candidate for COVID-19.
DATA SOURCES
PubMed/Medline, Embase, International Committee of Medical Journal Editors and International Clinical Trials Registry Platform clinical trial registries and medRxiv.
STUDY ELIGIBILITY CRITERIA AND PARTICIPANTS
All studies in humans or animals and randomized controlled trials (RCTs) in humans reporting primary data on prophylactic candidates against COVID-19, excluding studies focused on key populations.
INTERVENTIONS
PrEP and PEP candidate for COVID-19.
METHODS
Systematic review and qualitative synthesis of COVID-19 PrEP and PEP studies and RCTs complemented by search of medRxiv and PubMed and Embase for studies reporting RCT outcomes since systematic review search completion.
RESULTS
We identified 13 studies (from 2119 database records) and 117 RCTs (from 5565 RCTs listed in the registries) that met the inclusion criteria. Non-RCT studies reported on cross-sectional studies using hydroxychloroquine (HCQ) in humans (n = 2) or reported on animal studies (n = 7), most of which used antibodies. All five completed RCTs focused on the use of HCQ as either PrEP or PEP, and these and the cross-sectional studies reported no prophylactic effect. The majority of ongoing RCTs evaluated HCQ or other existing candidates including non-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, anti(retro)virals or use of vitamins and supplements.
CONCLUSIONS
The key message from completed studies and RCTs seems to be that HCQ does not work. There is little evidence regarding other compounds, with all RCTs using candidates other than HCQ still ongoing. It remains to be seen if the portfolio of existing molecules being evaluated in RCTs will identify successful prophylaxis against COVID-19 or if there is a need for the development of new candidates.
Topics: Animals; Antibodies, Monoclonal; Antibodies, Neutralizing; Antibodies, Viral; Antimalarials; Antiviral Agents; COVID-19; Humans; Hydroxychloroquine; Post-Exposure Prophylaxis; Pre-Exposure Prophylaxis; Randomized Controlled Trials as Topic; SARS-CoV-2; Vaccines
PubMed: 33476807
DOI: 10.1016/j.cmi.2021.01.013 -
Clinical Infectious Diseases : An... Sep 2022Rare cases of thrombosis and thrombocytopenia (thrombosis with thrombocytopenia syndrome [TTS]) have been associated with 2 coronavirus disease 2019 adenovirus vector... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Rare cases of thrombosis and thrombocytopenia (thrombosis with thrombocytopenia syndrome [TTS]) have been associated with 2 coronavirus disease 2019 adenovirus vector vaccines: the ChAdOx1 nCoV-19 Vaxzevria vaccine (Oxford/AstraZeneca) and the JNJ-7836735 Johnson & Johnson vaccine (Janssen). It is unknown if TTS is a class-mediated effect of adenovirus-based vaccines or if it could worsen known hypercoagulable states. Since most cases of TTS happen in women of childbearing age, pregnancy is a crucial risk factor to assess. Understanding these risks is important for advising vaccine recipients and future adenovirus vector vaccine development.
METHODS
To explore the potential associations of adenovirus-based vaccine components with symptoms of TTS in the general clinical trial population and in pregnant women in clinical trials, we conducted a systematic review and meta-analysis of adenovirus-based vector vaccines to document cases of thrombocytopenia, coagulopathy, and or pregnancy from 1 January 1966 to 9 August 2021.
RESULTS
We found 167 articles from 159 studies of adenovirus vector-based vaccines, 123 of which targeted infectious diseases. In the general population, 20 studies reported an event of thrombocytopenia and 20 studies indicated some coagulopathy. Among pregnant women, of the 28 studies that reported a total of 1731 pregnant women, thrombocytopenia or coagulopathy were not reported.
CONCLUSIONS
In this systematic review and meta-analysis, there was no class-wide effect of adenovirus vector vaccines toward thrombocytopenia or coagulopathy events in the general population or in pregnant women.
Topics: Adenoviridae; Adenovirus Vaccines; COVID-19; ChAdOx1 nCoV-19; Female; Humans; Pregnancy; Thrombocytopenia; Thrombosis; Vaccines
PubMed: 35134164
DOI: 10.1093/cid/ciac080 -
Journal of Infection and Public Health Mar 2023Globally, increasing coronavirus disease (COVID-19) vaccination coverage remains a major public health concern in the face of high rates of COVID-19 hesitancy among the... (Review)
Review
BACKGROUND
Globally, increasing coronavirus disease (COVID-19) vaccination coverage remains a major public health concern in the face of high rates of COVID-19 hesitancy among the general population. We must understand the impact of the determinants of COVID-19 vaccine uptake when designing national vaccination programmes. We aimed to synthesise nationwide evidence regarding COVID-19 infodemics and the demographic, psychological, and social predictors of COVID-19 vaccination uptake.
METHODS
We systematically searched seven databases between July 2021 and March 2022 to retrieve relevant articles published since COVID-19 was first reported on 31 December 2019 in Wuhan, China. Of the 12,502 peer-reviewed articles retrieved from the databases, 57 met the selection criteria and were included in this systematic review. We explored COVID-19 vaccine uptake determinants before and after the first COVID-19 vaccine roll-out by the Food and Drug Authority (FDA).
RESULTS
Increased COVID-19 vaccine uptake rates were associated with decreased hesitancy. Concerns about COVID-19 vaccine safety, negative side effects, rapid development of the COVID-19 vaccine, and uncertainty about vaccine effectiveness were associated with reluctance to be vaccinated. After the US FDA approval of COVID-19 vaccines, phobia of medical procedures such as vaccine injection and inadequate information about vaccines were the main determinants of COVID-19 vaccine hesitancy.
CONCLUSION
Addressing effectiveness and safety concerns regarding COVID-19 vaccines, as well as providing adequate information about vaccines and the impacts of pandemics, should be considered before implementation of any vaccination programme. Reassuring people about the safety of medical vaccination and using alternative procedures such as needle-free vaccination may help further increase vaccination uptake.
Topics: Humans; COVID-19 Vaccines; COVID-19; Vaccination; Vaccination Coverage; China; Vaccines
PubMed: 36738689
DOI: 10.1016/j.jiph.2023.01.020 -
Journal of Advanced Pharmaceutical... 2021Search for an effective and safe vaccine to prevent transmission of current pandemic is an unmet need. This study reviews and compares the available early phase clinical... (Review)
Review
Search for an effective and safe vaccine to prevent transmission of current pandemic is an unmet need. This study reviews and compares the available early phase clinical data of vaccine candidates which have reached phase 3 of clinical development. The latest update of "DRAFT landscape of coronavirus (CoV) disease 2019 candidate vaccines (October 2, 2020)" released by the World Health Organization was accessed to identify the potential vaccine candidates. The full text articles (published and/or preprint) of data of early clinical trials of the selected vaccines were accessed from the links provided in the same document, PubMed and/or medRxiv.com. After extraction and synthesis, the data were critically evaluated for the study efficacy and safety outcomes. Of the total 193 candidate vaccines 10 were found to reach phase 3 of the clinical development. Nine of these were included in the evaluation process. In all of the included studies, immunogenicity and serious adverse events/local or systemic adverse events/laboratory parameters abnormality was considered as efficacy and safety outcomes respectively. Immunogenicity response with most of the vaccines was either higher than or similar to the respective controls except one (recombinant adenovirus type 26 COV2 [Ad26.COV2.S]) for which it was less than that in control. Overall adverse events (related and/or unrelated) were more with vaccines than those with respective control(s) in three studies, in other two, these were similar whereas in one study, the events were less in the vaccine group than in control group and in the rest, data described were descriptive only without any mention for the same for the control. In conclusion all studies showed immunogenic response to target protein of severe acute respiratory syndrome CoV-2 and which was higher than the respective control except for Ad26.CoV2.S. Many of the vaccines caused more adverse events than the controls, however most were mild and transient and/or manageable.
PubMed: 34345597
DOI: 10.4103/japtr.JAPTR_229_20 -
BMJ Global Health Oct 2023Maternal vaccination is a promising strategy to reduce the burden of vaccine-preventable diseases for mothers and infants. We aimed to provide an up-to-date overview of... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Maternal vaccination is a promising strategy to reduce the burden of vaccine-preventable diseases for mothers and infants. We aimed to provide an up-to-date overview of the efficacy and safety of all available maternal vaccines.
METHODS
We searched PubMed, Embase, CENTRAL and ClinicalTrials.gov on 1 February 2022, for phase III and IV randomised controlled trials (RCTs) that compared maternal vaccination against any pathogen with placebo or no vaccination. Primary outcomes were laboratory-confirmed or clinically confirmed disease in mothers and infants. Secondary safety outcomes included intrauterine growth restriction, stillbirth, maternal death, preterm birth, congenital malformations and infant death. Random effects meta-analysis were used to calculate pooled risk ratio's (RR). Quality appraisal was performed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE).
RESULTS
Six RCTs on four maternal vaccines, influenza, tetanus, diphtheria and pertussis (Tdap), pneumococcal and respiratory syncytial virus (RSV) were eligible. The overall risk of bias and certainty of evidence varied from low to high. Maternal influenza vaccination significantly reduced the number of laboratory-confirmed influenza cases (RR 0.58, 95% CI 0.42 to 0.79, event rate 57 vs 98, 2 RCTs, n=6003, I=0%), and clinically confirmed influenza cases in mothers (RR 0.88, 95% CI 0.78 to 0.99, event rate 418 vs 472, 2 RCTs, n=6003, I=0%), and laboratory-confirmed influenza in infants (RR 0.66, 95% CI 0.52 to 0.85, event rate 98 vs 148, 2 RCTs, n=5883, I=0%), although this was not significant for clinically confirmed influenza in infants (RR 0.99, 95% CI 0.94 to 1.05, event rate 1371 vs 1378, 2 RCTs, n=5883, I=0%). No efficacy data were available on maternal Tdap vaccination. Maternal pneumococcal vaccination did not reduce laboratory-confirmed and clinically confirmed middle ear disease (RR 0.49, 95% CI 0.24 to 1.02, event rate 9 vs 18, 1 RCT, n=133 and RR 0.88 95% CI 0.69 to 1.12, event rate 42 vs 47, 1 RCT, n=133, respectively), and clinically confirmed lower-respiratory tract infection (LRTI) (RR 1.08, 95% CI 0.82 to 1.43, event rate 18 vs 34, 1 RCT, n=70) in infants. Maternal RSV vaccination did not reduce laboratory-confirmed RSV LRTI in infants (RR 0.75, 95% CI 0.56 to 1.01, event rate 103 vs 71, 1 RCT, n=4527). There was no evidence of a significant effect of any of the maternal vaccines on the reported safety outcomes.
CONCLUSIONS
The few RCTs with low event rates suggest that, depending on the type of maternal vaccine, the vaccine might effectively prevent disease and within its size does not show safety concerns in mothers and infants.
PROSPERO REGISTRATION NUMBER
CRD42021235115.
Topics: Infant, Newborn; Female; Humans; Infant; Influenza, Human; Influenza Vaccines; Mothers; Vaccination; Respiratory Tract Infections; Randomized Controlled Trials as Topic
PubMed: 37899087
DOI: 10.1136/bmjgh-2023-012376 -
Public Health Nov 2022Patients with cancer are more vulnerable to COVID-19 morbidity and morbidity than the general population and have been prioritised in COVID-19 vaccination programmes.... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
Patients with cancer are more vulnerable to COVID-19 morbidity and morbidity than the general population and have been prioritised in COVID-19 vaccination programmes. This study aims to investigate COVID-19 vaccine acceptance and hesitancy among patients with cancer.
STUDY DESIGN
This was a systematic review and meta-analysis.
METHODS
PubMed, ScienceDirect and the Cochrane COVID-19 study registry were searched in addition to secondary literature using a predefined search method. Two authors independently performed the study identification, screening and eligibility assessment. This study followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses 2020 guidelines and Joanna Brides' Institute quality appraisal tools.
RESULTS
A total of 29 studies and reports were selected for the final review. The pooled prevalence of vaccine acceptance was 59% (95% confidence interval 52-67%, I: 99%). Concerns about vaccine-related side-effects, uncertainty about vaccine efficacy and safety, ongoing active anticancer therapies and scepticism about rapid vaccine development were the leading causes for vaccine hesitancy. Female gender and undergoing active anticancer treatments were significant factors associated with COVID-19 vaccine hesitancy. Early cancer stages (stages I and II) and good compliance with prior influenza vaccinations were significant factors associated with the acceptance of the COVID-19 vaccine.
CONCLUSIONS
Many patients with cancer are hesitant about COVID-19 vaccination. Well-designed problem-based educational interventions will increase compliance with COVID-19 vaccination.
Topics: Humans; Female; COVID-19 Vaccines; COVID-19; Vaccination Refusal; Vaccination; Vaccines; Neoplasms
PubMed: 36244261
DOI: 10.1016/j.puhe.2022.09.001 -
Vaccines Nov 2023Delivering vaccines in humanitarian response requires rigourous and continuous analysis of evidence. This systematic review mapped the normative landscape of vaccination... (Review)
Review
Delivering vaccines in humanitarian response requires rigourous and continuous analysis of evidence. This systematic review mapped the normative landscape of vaccination guidance on vaccine-preventable diseases in crisis-affected settings. Guidance published between 2000 and 2022 was searched for, in English and French, on websites of humanitarian actors, Google, and Bing. Peer-reviewed database searches were performed in Global Health and Embase. Reference lists of all included documents were screened. We disseminated an online survey to professionals working in vaccination delivery in humanitarian contexts. There was a total of 48 eligible guidance documents, including technical guidance ( = 17), descriptive guidance ( = 16), operational guidance ( = 11), evidence reviews ( = 3), and ethical guidance ( = 1). Most were World Health Organization documents ( = 21) targeting children under 5 years of age. Critical appraisal revealed insufficient inclusion of affected populations and limited rigour in guideline development. We found limited information on vaccines including, yellow fever, cholera, meningococcal, hepatitis A, and varicella, as well as human papilloma virus (HPV). There is a plethora of vaccination guidance for vaccine-preventable diseases in humanitarian contexts. However, gaps remain in the critical and systematic inclusion of evidence, inclusion of the concept of "zero-dose" children and affected populations, ethical guidance, and specific recommendations for HPV and non-universally recommended vaccines, which must be addressed.
PubMed: 38140148
DOI: 10.3390/vaccines11121743